FDA Adverse Event
Malfunction
Summary report: N
SENSOR ENLITE
MDR report key: 4386701
·
Received December 6, 2014
Report
- Report Number
- 2032227-2014-62304
- Event Type
- Malfunction
- Date Received
- December 6, 2014
- Date of Event
- January 1, 2014
- Report Date
- November 11, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINDINGS: RELIABILITY ANALYSIS INSPECTED 1 OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST ((B)(4)). SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. ET (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S SENSORS WERE ONLY LASTING ONE TO TWO DAYS. HER BLOOD GLUCOSE WAS 124 MG/DL AT THE TIME OF REPORTING. SHE STATED THAT SHE WAS ALSO RECEIVING LOW THRESHOLD SUSPENDS ON HER INSULIN PUMP. THE SENSOR WAS RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788996 | SENSOR ENLITE | OZO | MEDTRONIC MINIMED | MMT-7008A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |